GT Biopharma Announces Postive Results For Two Next Generation Trikes In Solid Tumors

GT Biopharma Inc. (GTBP) and (Euronext Paris: GTBP) announced today the positive results for two next generation Trispecific Killer Engagers (TriKEs) in solid tumors. These efforts were headed by Dr. Daniel Vallera, Director, Section of Molecular Cancer Therapeutics and Dr. Martin Felices, Co-Director of the Translational Therapy Laboratory at the Masonic Cancer Center, University of Minnesota.

Two animal models were tested. One in ovarian cancer and one in head and neck cancers. In the ovarian cancer model, animals that were treated with our CD16-IL15-B7H3 TriKE demonstrated significant tumor resolution. An additional observation was the persistence of natural killer (NK) cells in the treated animals which is thought to be directly related to its tumor-killing abilities. In the head and neck cancer animal model, animals treated with our CD16-IL15-EpCAM TriKE displayed a significant decrease in tumor burden.

Solid tumors represent approximately 80% of all cancers. In addition, there are tremendous unmet medical needs in both ovarian and head and neck cancers.

Dr. Martin Felices said, “These promising results certainly warrant further investigation. If these results are seen in human ovarian as well as head and neck cancers it can dramatically change the poor outcomes these patients currently face.”

Dr. Daniel Vallera said: “Based on this compelling data we continue to be incredibly excited about the use of the TriKEs in solid tumors. This would be a ground-breaking advancement for the treatment of these hard to treat cancers.”

GT Biopharma’s Chairman and Chief Executive Officer (CEO) Dr. Raymond Urbanski said: “These results further demonstrate the immense potential of our NK cell engager TriKE and TetraKE platforms for the treatment of both liquid and solid tumors. They could represent a complete paradigm shift in the treatment of cancer”

About GT Biopharma, Inc.: GT Biopharma, Inc. is a clinical-stage biopharmaceutical company predominantly focused on the development and commercialization of immuno-oncology products based off our proprietary Tri-specific Killer Engager (TriKE), Tetra-specific Killer Engager (TetraKE) and bi-specific Antibody Drug Conjugate (ADC) technology platforms. Our TriKE and TetraKE platforms generate proprietary moieties designed to harness and enhance the cancer-killing abilities of a patient’s own natural killer, or NK, cells. Once bound to an NK cell, our moieties are designed to enhance the NK cell and precisely direct it to one or more specifically-targeted proteins (tumor antigens) expressed on a specific type of cancer, ultimately resulting in the cancer cell’s death. TriKEs and TetraKEs are made up of recombinant fusion proteins, can be designed to target certain tumor antigens on hematologic malignancies, sarcomas or solid tumors and do not require patient-specific customization. They are designed to be dosed in a common outpatient setting similar to modern antibody therapeutics and are expected to have a reasonably low cost of goods. Our ADC platform can generate product candidates that are bi-specific, ligand-directed single-chain fusion proteins that, we believe, represent the next generation of ADCs.

GT’s nervous system platform is focused on acquiring or discovering and patenting late-stage, de-risked, and close-to-market improved treatments for nervous system diseases (Neurology and Pain) and shepherding them through the approval process to the NDA. GT Biopharma’s neurology products currently include PainBrake, as well as treatments for the symptoms of myasthenia gravis, and motion sickness.

Except for historical information contained herein, the statements in this release are forward-looking and made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently unreliable and actual results may differ materially. Examples of forward-looking statements in this news release include statements regarding the payment of dividends, marketing and distribution plans, development activities and anticipated operating results. Factors which could cause actual results to differ materially from these forward-looking statements include such factors as the Company’s ability to accomplish its business initiatives, significant fluctuations in marketing expenses and ability to achieve and expand significant levels of revenues, or recognize net income, from the sale of its products and services, as well as the introduction of competing products, or management’s ability to attract and maintain qualified personnel necessary for the development and commercialization of its planned products, and other information that may be detailed from time to time in the Company’s filings with the United States Securities and Exchange Commission. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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